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Monoclonal Antibodies

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks

Summary

This trial tests a new medicine on people with moderate to severe rheumatoid arthritis. It aims to reduce inflammation and joint damage in those who may not respond well to other treatments.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Secondary study objectives
Diabetes Insipidus
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: NipocalimabExperimental Treatment1 Intervention
Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.
Group II: Group 1: PlaceboPlacebo Group1 Intervention
Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,850 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
722 Patients Enrolled for Rheumatoid Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,877 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
322 Patients Enrolled for Rheumatoid Arthritis
~13 spots leftby Dec 2025
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